DIN EN ISO 10555-6:2017-11

This International Standard specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use. Requirements, performance, and user safety issues related to non-coring needles are excluded. This document has been prepared by Technical Committee ISO/TC 84 (secretariat: DS, Denmark) in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN). At DIN, the German Institute for Standardization e. V., the responsible committee is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") at DIN Standards Committee Medicine (NAMed). This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). The informative Annex ZA is attached to this version.